{"id":57969,"date":"2025-01-06T10:07:05","date_gmt":"2025-01-06T10:07:05","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/soumettre-une-demande-de-nouveau-medicament-nda-aux-etats-unis\/"},"modified":"2025-01-06T10:07:05","modified_gmt":"2025-01-06T09:07:05","slug":"soumettre-une-demande-de-nouveau-medicament-nda-aux-etats-unis","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/soumettre-une-demande-de-nouveau-medicament-nda-aux-etats-unis\/","title":{"rendered":"Soumettre une demande de nouveau m\u00e9dicament (NDA) aux \u00c9tats-Unis"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Ma\u00eetrisez les complexit\u00e9s du processus de demande de nouveau m\u00e9dicament (NDA) aux \u00c9tats-Unis. Ce cours certifi\u00e9 offre une analyse claire des exigences de soumission, fournissant des strat\u00e9gies pratiques (contenu \u00e0 soumettre, formatage et fonctionnement du processus d\u2019examen) pour garantir la <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/inspections-de-conformite-reglementaire-et-audits-externes\/\">conformit\u00e9<\/a> et optimiser chaque \u00e9tape de l\u2019obtention d\u2019une approbation de m\u00e9dicament aux \u00c9tats-Unis.  <\/span><\/p>\n<div class=\"flex max-w-full flex-col grow\">\n<div class=\"min-h-8 text-message relative flex w-full flex-col items-end gap-2 text-start break-words whitespace-normal [.text-message+&amp;]:mt-5\" dir=\"auto\" data-message-author-role=\"assistant\" data-message-id=\"be129194-f5ed-4d72-8aff-112053cfc6c1\" data-message-model-slug=\"gpt-4o\">\n<div class=\"flex w-full flex-col gap-1 empty:hidden first:pt-[3px]\">\n<div class=\"markdown prose dark:prose-invert w-full break-words light\">\n<p data-start=\"0\" data-end=\"277\" data-is-last-node=\"\" data-is-only-node=\"\">\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><b>\u00c0 qui s\u2019adresse ce cours ?<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Ce cours est con\u00e7u pour les <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/specialiste-des-affaires-reglementaires\/\">professionnels des affaires r\u00e9glementaires<\/a>, les sp\u00e9cialistes de l\u2019assurance qualit\u00e9, les chefs de projet pharmaceutique et les \u00e9quipes de d\u00e9veloppement de produits. Il est id\u00e9al pour les personnes pr\u00e9parant des NDA pour la FDA ou pour quiconque souhaitant comprendre le cadre r\u00e9glementaire am\u00e9ricain des nouveaux m\u00e9dicaments. <\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>Sujets abord\u00e9s dans le cours :<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Exigences cl\u00e9s pour la <a href=\"https:\/\/www.fda.gov\/drugs\/types-applications\/new-drug-application-nda\">soumission d\u2019une NDA<\/a> et calendriers r\u00e9glementaires.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Structuration et pr\u00e9paration du dossier technique commun (CTD).<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Gestion des interactions avec la FDA, y compris les r\u00e9unions de pr\u00e9-soumission.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Strat\u00e9gies pour g\u00e9rer les questions et les modifications post-soumission.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Garantir la conformit\u00e9 des sections cliniques, non cliniques et de fabrication.<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>Chaque session comprend des exemples concrets et des \u00e9valuations pour un apprentissage pratique et appliqu\u00e9. \u00c0 l\u2019issue de la formation, les participants re\u00e7oivent un certificat reconnu mondialement, tra\u00e7able et valide pour les audits. <\/p>\n<p>&nbsp;<\/p>\n<h3><b>Programme :<\/b><\/h3>\n<p><b>Introduction<\/b><\/p>\n<p><b>Le\u00e7on 1 : Pr\u00e9sentation de la NDA<\/b><\/p>\n<p><b>Le\u00e7on 2 : Contenu et format de la NDA<\/b><\/p>\n<p><b>Le\u00e7on 3 : Informations administratives (Module 1)<\/b><\/p>\n<p><b>Le\u00e7on 4 : R\u00e9sum\u00e9s du dossier technique commun (Module 2)<\/b><\/p>\n<p><b>Le\u00e7on 5 : Informations sur la qualit\u00e9 (Module 3)<\/b><\/p>\n<p><b>Le\u00e7on 6 : Rapports d\u2019\u00e9tudes non cliniques (Module 4)<\/b><\/p>\n<p><b>Le\u00e7on 7 : Rapports d\u2019\u00e9tudes cliniques (Module 5)<\/b><\/p>\n<p><b>Le\u00e7on 8 : Processus d\u2019examen et d\u2019approbation de la NDA<\/b><\/p>\n<p><b>Conclusion<\/b><\/p>\n<p><b>\u00c9valuation<\/b><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ma\u00eetrisez les complexit\u00e9s du processus de demande de nouveau m\u00e9dicament (NDA) aux \u00c9tats-Unis. Ce cours certifi\u00e9 offre une analyse claire des exigences de soumission, fournissant des strat\u00e9gies pratiques (contenu \u00e0 soumettre, formatage et fonctionnement du processus d\u2019examen) pour garantir la conformit\u00e9 et optimiser chaque \u00e9tape de l\u2019obtention d\u2019une approbation de m\u00e9dicament aux \u00c9tats-Unis. \u00c0 qui [&hellip;]<\/p>\n","protected":false},"featured_media":51150,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,258],"product_tag":[],"class_list":{"0":"post-57969","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-pharmaceutique","9":"first","10":"instock","11":"taxable","12":"shipping-taxable","13":"purchasable","14":"product-type-subscription"},"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":null,"bundle_virtual":false,"bundle_layout":"","bundle_add_to_cart_form_location":"","bundle_editable_in_cart":false,"bundle_sold_individually_context":"","bundle_item_grouping":"","bundle_min_size":"","bundle_max_size":"","bundle_price":[],"bundled_items":[],"bundle_sell_ids":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Cours de formation certifi\u00e9 sur la soumission d\u2019une demande de nouveau m\u00e9dicament (NDA)<\/title>\n<meta name=\"description\" content=\"Ma\u00eetrisez le processus NDA. 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